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OpenTrials
Completed

NCT Number: NCT02048449

Inter-rater Reliability of the Reflux Finding Score Among Gastroenterologists

Title:

Inter-rater reliability of the reflux finding score based on endoscopic laryngeal findings in the diagnosis of laryngopharyngeal reflux disease

Participants:

Voluntary participants after invitation among members (a total of about 40 gastroenterologists) of Gangwon Branch of Korean Society of Gastrointestinal Endoscopy and an otorhinolaryngologist

Primary endpoint:

Interrater reliability (Kappa coefficient) on the sum of reflux finding score more than 7 points between an otorhinolaryngologist and gastroenterologists (7 points means the cut-off value for the diagnosis of laryngopharyngeal reflux disease)

Secondary endpoint:

Agreement (%) on 8 items of reflux finding score for laryngopharygeal reflux among gastroenterologists

Completed

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Key information

About this study

Study Design

  • Recruitment of doctor participants: introduction by e-mail
  • Education on reflux finding score - standardized materials (instructional video)
  • PRETEST (15 pictures) / feedback (at-a-glance assessment format)
  • TEST 1 (50 pictures) - Acess format including 8 items at each pictures
  • Feedback education (individualized intruction of an otorhinolaryngologist)
  • TEST 2 (50 pictures) - Acess format including 8 items at each pictures
  • Test-Retest reliability - repeat Test 2 with 1 week interval (Participants should take retest of TEST 2 with the concealment of the answer)
  • Analysis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants: Gastroenterologists (GI specialists) or trainees /
  • Pictures: Endoscopic laryngeal pictures with good quality

Exclusion criteria

  • Participants: Major other than gastroenterology /
  • Pictures: Endoscopic laryngeal pictures without good quality

Treatment and study plan

Primary outcomes

  1. Cohen's kappa coefficient

    Time frame: 5 months

    Cohen's Kappa coefficient based on the sum of reflux finding scores (7 points or more than 7) for the diagnosis of laryngopharyngeal reflux disease between an otorhinolaryngologist (reference) and participant gastroenterologists

Secondary outcomes

  1. Agreement (%) at each item out of 8 items of reflux finding score

    Time frame: 5 months

    Agreement (%) at each item out of 8 items (subglottic edema, ventricular obliteration, laryngeal erythema, vocal cord edema, diffuse laryngeal edema, posterior commissure hypertrophy, laryngeal granuloma, thick endolaryngeal mucus) of reflux finding score

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Official study title

Inter-rater Reliability of the Reflux Finding Score Based on Endoscopic Laryngeal Findings in the Diagnosis of Laryngopharyngeal Reflux Disease

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2014
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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